Fragmin

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Epidural or spinal hematomas
may occur in patients who are anticoagulated with low molecular weight heparins
(LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing
spinal puncture. These hematomas may result in long-term or permanent
paralysis. Consider these risks when scheduling patients for spinal procedures.
Factors that can increase the risk of developing epidural or spinal hematomas
in these patients include:

Use of indwelling epidural catheters

Concomitant use of other drugs that affect hemostasis,
such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors,
other anticoagulants.

A history of traumatic or repeated epidural or spinal
punctures

A history of spinal deformity or spinal surgery

Optimal timing between the administration of FRAGMIN
and neuraxial procedures is not known

Monitor patients frequently for signs and
symptoms of neurological impairment. If neurological compromise is noted,
urgent treatment is necessary. Consider the benefits and risks before neuraxial
intervention in patients anticoagulated or to be anticoagulated for
thromboprophylaxis [see WARNINGS AND
PRECAUTIONS and DRUG INTERACTIONS].

Each prefilled syringe also contains Water for Injection
and sodium chloride, when required, to maintain physiologic ionic strength. The
prefilled syringes are preservative-free. Each multiple-dose vial also contains
Water for Injection and 14 mg of benzyl alcohol per mL as a preservative. The
pH of both formulations is 5.0 to 7.5. [See DOSAGE AND ADMINISTRATION and
HOW SUPPLIED]

Dalteparin sodium is produced through controlled nitrous
acid depolymerization of sodium heparin from porcine intestinal mucosa followed
by a chromatographic purification process. It is composed of strongly acidic
sulfated polysaccharide chains (oligosaccharide, containing
2,5-anhydro-D-mannitol residues as end groups) with an average molecular weight
of 5000 and about 90% of the material within the range 2000–9000. The molecular
weight distribution is:

What are the precautions when taking dalteparin (Fragmin)?

Before using dalteparin, tell your doctor or pharmacist if you are allergic to it; or to heparins or pork products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.